The following data is part of a premarket notification filed by Intl. Mycoplasma/mdc Assoc. with the FDA for Serofast.
Device ID | K903958 |
510k Number | K903958 |
Device Name: | SEROFAST |
Classification | Antisera, All Mycoplasma Spp. |
Applicant | INTL. MYCOPLASMA/MDC ASSOC. P.O. BOX 641 Manchester, MA 01944 |
Contact | Fran Griggs |
Correspondent | Fran Griggs INTL. MYCOPLASMA/MDC ASSOC. P.O. BOX 641 Manchester, MA 01944 |
Product Code | GSA |
CFR Regulation Number | 866.3375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-28 |
Decision Date | 1990-12-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SEROFAST 74217084 not registered Dead/Abandoned |
International Mycoplasma 1991-10-30 |